Micromanaging Human Sleep Physiology to Treat Sleep Apnea and Other Disorders

NCT ID: NCT06926036

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2027-04-30

Brief Summary

This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing changes during sleep and subsequent cognitive benefits during wake.

Participants with obstructive sleep apnea (who have not yet been treated for sleep apnea) will be recruited. Participants will engage in breath training for one week in their own homes and to record their sleep at home using commercially available mobile devices and subsequently have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting.

Conditions

Sleep Apnea Obstructive (OSA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

All participants

Group Type: EXPERIMENTAL

Wake training + TMR

Intervention Type: BEHAVIORAL

In this within-participant design, all participants will undergo the same intervention of waking training and TMR.

Waking training - waking training will associate an auditory cue with a specific learned behavioral response (a tongue protrusion and inhalation) during daily sessions for approximately one week, with home sleep monitoring.

TMR - Targeted memory reactivation (TMR) refers to the process of playing learning-associated audio cues quietly during sleep in order to reactivate memories associated with the cue. After completion of waking training, TMR occurs in a laboratory setting, with PSG recording, during a single night.

Interventions

Wake training + TMR

In this within-participant design, all participants will undergo the same intervention of waking training and TMR.

Waking training - waking training will associate an auditory cue with a specific learned behavioral response (a tongue protrusion and inhalation) during daily sessions for approximately one week, with home sleep monitoring.

TMR - Targeted memory reactivation (TMR) refers to the process of playing learning-associated audio cues quietly during sleep in order to reactivate memories associated with the cue. After completion of waking training, TMR occurs in a laboratory setting, with PSG recording, during a single night.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Right-handed, English-speaking adults, 18-60 years old who report normal hearing during sleep

2. Participants with suspected obstructive sleep apnea (OSA) (including those who have been diagnosed by a physician and those whose self-reported symptoms of OSA on the STOP-BANG questionnaire classify them as being "individuals with intermediate to high risk".

3. No report of any other sleep disorder besides OSA.

4. No report of any neurological or cardiometabolic diseases or disorders.

5. Not currently under active treatment for sleep apnea.

6. BMI ≤ 40.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Ken Paller

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ken A Paller, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ken A Paller, PhD

Role: CONTACT

kap@northwestern.edu

847-467-3370

Facility Contacts

Ken A Paller, PhD

Role: primary

kap@northwestern.edu

847-467-3370

Other Identifiers

FP00002577

Identifier Type: -

Identifier Source: org_study_id